Hyftor — Blue Cross Blue Shield of Alabama

Initial criteria

• Diagnosis of tuberous sclerosis complex (TSC) confirmed by ONE of the following: • The patient has two major features OR one major and two minor features of TSC clinical diagnostic criteria (Major features: hypomelanotic macules [≥3, at least 5 mm diameter], angiofibroma [≥3] or fibrous cephalic plaque, ungual fibromas [≥2], shagreen patch, multiple retinal hamartomas, multiple cortical tubers and/or radial migration lines, subependymal nodule [≥2], subependymal giant cell astrocytoma, cardiac rhabdomyoma, lymphangiomyomatosis (LAM), angiomyolipomas [≥2]; note that a combination of LAM and angiomyolipomas without other features does not meet the criteria for a definite diagnosis. Minor features: 'confetti' skin lesions, dental enamel pits [≥3], intraoral fibromas [≥2], retinal achromic patch, multiple renal cysts, nonrenal hamartomas, sclerotic bone lesions) OR • The patient has a pathogenic variant in the TSC1 or TSC2 gene confirmed by genetic testing
• The patient has three or more facial angiofibromas
• If the patient has an FDA labeled indication, ONE of the following: • The patient’s age is within FDA labeling for the requested indication (age ≥6 years) OR • There is support for using the requested agent for the patient’s age for the requested indication
• The prescriber is a specialist in the area of the patient’s diagnosis (e.g., dermatologist, geneticist) or has consulted with a specialist in that area
• The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
• The patient has had clinical benefit with the requested agent
• The prescriber is a specialist in the area of the patient’s diagnosis (e.g., dermatologist, geneticist) or has consulted with a specialist in that area
• The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 weeks initial, 12 months renewal